Assessing a Stem Cell Therapy for Spina Bifida in English Bulldog Puppies

UC Davis Veterinary Medicine

"Help us find a treatment for spina bifida in dogs using stem cells!"

Animal:

Dogs

Age:

Less than 10 weeks of age

Sex:

Any

Keywords:

spina bifida, stem cell, dog, canine, stem cell therapy, SB, healthy

Type:

Other - Stem Cells

Target:

12 Participants

Investigator:

Background and purpose

Spina bifida (SB) occurs due to malformation of the spinal cord and/or vertebrae during pregnancy. It markedly affects the quality of a dog’s life. They have difficulties walking, or cannot walk at all, and are incontinent, predisposing them to repeated skin and urinary tract infections. As such, they do not make good pets for people and most often they are euthanized at a young age. The purpose of this study is to assess the efficacy of a novel stem cell therapy for spina bifida in English Bulldogs and compare the effects of reparative surgery alone to surgery plus a gel matrix and stem cell therapy for these dogs.

Normal, healthy English Bulldogs will also be enrolled. Information collected from these dogs will be compared to the bulldogs with spina bifida to give us information on what the normal bulldog spine looks like and how the bulldog breed normally moves. With this information we can get a better sense of how well our treatment works in bulldogs who have spina bifida.

What happens in this study

For dogs with spina bifida:

Visit 1: A physical exam, blood and urine analysis, video-recorded gait analysis, assessment of incontinence, electrodiagnostic studies, an MRI, cerebral spinal fluid (CSF) collection and surgical correction with or without stem cell treatment while under general anesthesia.
Visit 2 (8 weeks post surgery): A physical exam, video-recorded gait analysis, assessment of incontinence, electrodiagnostic studies, an MRI, and CSF collection while under general anesthesia.
Visits 3-5 (6, 9 and 12 months post surgery): A physical exam, videorecorded gait analysis and assessment of incontinence.

For healthy dogs:

Visit 1: A physical exam, blood and urine analysis, video-recorded gait analysis, and assessment of incontinence are all performed while the puppy is awake. Under anesthesia, puppies will have an MRI, electrodiagnostic studies, and a small amount of cerebral spinal fluid (CSF) will be collected. These events may occur on the same day or over 2 consecutive days.
Visit 2 (8 weeks after visit #1): A physical exam, video-recorded gait analysis and assessment of incontinence will be performed with the puppy awake. Under anesthesia, electrodiagnostic studies will be performed. If you’d like to have your puppy spayed or neutered, the costs of the surgery will be covered if the procedure is performed during this visit while the puppy is already under anesthesia. These events may occur on the same day or over 2 consecutive days.
Visits 3-5 (6, 9 and 12 months post surgery): A physical exam, video-recorded gait analysis and assessment of incontinence. No anesthesia is needed for these final appointments.

Pet owner responsibilities

If you allow your dog with SPINA BIFIDA to participate in this study, you will be responsible for:

Keeping all scheduled appointments
Covering any costs extending beyond routine recovery from surgery and anything beyond the $4000 credit towards medical treatment of any adverse events and any other non-study related procedure costs.
Covering costs associated with routine spay/neuter or elective surgeries, vaccinations or other breed related conditions that might need treatment (e.g., cherry eye).

If you allow your HEALTHY dog to participate in this study, you will be responsible for:

Keeping all scheduled appointments
Covering any costs extending beyond routine recovery from surgery and anything beyond the $4000 credit towards medical treatment of any adverse events and any other non-study related procedure costs.

Participation requirements

We are looking for English Bulldog puppies (less than 10 weeks old) that have clinical signs compatible with spina bifida (including difficulty walking and/or incontinence), have radiographs taken to confirm the presence of spina bifida in the lower lumbar region, and are deemed healthy in all other respects.

We are also looking for normal, healthy English bulldog puppies that are up to 10 weeks in age.

Benefits and risks of participating

For your dog with spina bifida, participation in this trial will hopefully increase your dog’s ability to walk more normally and improve urinary and fecal incontinence.

By studying the movement and bladder/bowel function of healthy, normal English bulldogs, we will be able to determine how well our novel stem cell treatment is working in the English bulldogs who have spina bifida. Without normal healthy bulldogs, we would not be able to see function improvements in the spina bifida dogs after stem cell treatment.

Compensation

For dogs with spina bifida, the study will cover all study-related costs and up to $4000 to cover any complications associated with the procedure. If qualified, there may be funds available to cover related corrective orthopedic procedures that influence movement.

For healthy dogs, the study will cover all study-related costs including up to $4000 to cover any complications associated with procedures. Additionally, the study will cover costs for the routine spay/neuter, a full set of puppy vaccinations, a 12-month supply of Nexguard flea & tick prevention and a 12-month supply of Heartguard Plus heartworm prevention.

Resources

PDF Docs

Clinical Trial Informational Flyer

Download

Links

Spina Bifida Clinical Trial Featured on Good Day Sacramento

Visit Link

Study ID

IACUC: 20415

Schedule

Study duration and period

Participation in this clinical trial will last for 12 months.